Tag: fingolimod
-
Gilenya Safety Alert November 2020: Cases of Acute Liver Failure Requiring Liver Transplant
European Medicines Agency (EMA) and Novartis Issue Dear Doctor Letter About Gilenya Label Change (Posted by Tom Lamb at DrugInjuryWatch.com) A recent periodic review of Gilenya safety data by the European Medicines…
-
Gilenya Birth Defects Warnings Issued By Drug Safety Regulators In Canada And Europe — But Not By FDA In The US
Gilenya Increased Risk of Major Congenital Malformations Such As Renal / Kidney And Musculoskeletal Abnormalities, Atrial Septal Defects (Posted by Tom Lamb at DrugInjuryWatch.com) On December 19, 2019 Health Canada issued a…
-
Potential Link Between MS Drug Gilenya And Cancers, Neoplasms, Or Tumors According To Health Canada
This September 2015 Drug Safety Alert Is Based Primarily On Reports Of Skin Cancer And Lymphoma Blood Cancer (Posted by Tom Lamb at DrugInjuryWatch.com) Health Canada recently conducted a review of safety…
-
August 2015 Gilenya Label Change About PML Brain Infection Follows FDA Drug Safety Alert About This Serious Side Effect
These Two PML Cases Did Not Involve The Patients Previously Using The MS Drug Tysabri, As Did The One Which FDA Reported In August 2013 (Posted by Tom Lamb at DrugInjuryWatch.com) ________________________________…
-
A New Case Of Progressive Multifocal Leukoencephalopathy (PML) In A Patient Using Gilenya Is Reported By Novartis In Canada
Company Is Investigating This Gilenya – PML Case To See Whether Brain Disease Might Be A Side Effect Of Its MS Drug (Posted by Tom Lamb at DrugInjuryWatch.com) Gilenya (fingolimod) capsules were approved by the FDA in…
-
Various Drug Safety Issues Continue To Be Associated With Novartis Multiple Sclerosis (MS) Medication Gilenya
ISMP QuarterWatch Report From 2014 States Adverse Events Reports Show That Gilenya Cardiac Risks "were neither rare nor hypothetical" (Posted by Tom Lamb at DrugInjuryWatch.com)The safety profile for the Novartis drug Gilenya (fingolimod) has been controversial for…
-
Multiple Sclerosis (MS) Medication Gilenya: Timeline Of Actions Taken In US, Canada, And Europe
Increasing Safety Concerns About Novartis Drug Gilenya Are Primarily Cardiovascular Side Effects And Unexplained Death (Posted by Tom Lamb at DrugInjuryWatch.com) In August 2012 Health Canada issued the latest drug safety alert concerning Gilenya…